What you should know about the two recalls issued by Alere in 2014
In 2014, Alere San Diego, Inc. (a wholly owned subsidiary of medical device maker Alere) issued a pair of voluntary recalls in relation to its INRatio PT/INR Monitor System and Test Strips, which track a patient’s PT/INR levels while taking a blood thinning drug like warfarin. Alere issued the recalls because the INRatio Monitor System gave patients erroneously low PT/INR readings when the actual reading was many times higher, putting the patients at risk for serious and potentially deadly bleeding events.
What is a “voluntary” recall?
The vast majority of medical device recalls are classified as “voluntary.” The U.S. Food and Drug Administration (FDA) rarely issues a court-ordered mandatory recall for a defective medical device.
The FDA will issue a mandatory recall only when a manufacturer refuses to voluntarily recall its medical device, which is extremely rare because such behavior jeopardizes the company’s future ability to obtain FDA approval.
Alere INRatio PT/INR Test Strip April 2014 recall
In April 2014, Alere issued a voluntary recall for its INRatio2 PT/INR Professional Test Strips after receiving nine reports of serious bleeding events, which included three deaths. The INRatio2 Professional Test Strips are part of Alere’s INRatio2 PT/INR Professional Monitoring System for use by physicians in checking the clotting time of their patients’ blood while prescribed to warfarin.
The April 2014 recall only affected the Test Strips associated with the INRatio2 PT/INR monitoring system. They were manufactured between August 2013 and April 2014. Patients and healthcare providers were advised to transition to the first generation INRatio monitoring system test strips
The INRatio2 is the second generation of PT/INR Monitor System. The April 2014 recall only applied to INRatio test strips used by professional healthcare providers.
December 2014 recall: Alere INRatio PT/INR Monitoring System and Test strips
Alere issued its second voluntary recall associated with its INRatio PT/INR monitoring system in December 2014, this time recalling both the Monitor System and Test Strips for its first and second generation INRatio Professional and Home PT/INR Monitor System. The expanded recall included the Monitor System and Test Strips manufactured between April 2008 and December 2014.
Alere admitted to the FDA it received almost 19,000 complaints of malfunction related to its INRatio Monitor System and Test Strips between 2013 and 2014. Patients with certain medical conditions, including anemia, unusual bleeding or bruising, or conditions with elevated fibrinogen, were at special risk of receiving inaccurate PT/INR readings.
Alere INRatio PT/INR Monitor System and Test Strips Class I Recall
Both of the 2014 recall alerts for the Alere INRatio PT/INR Monitor System and Test Strips were classified as Class I recalls. Class I is the most serious type of recall for medical devices because use of such devices will likely result in serious injury or death to the user.
The Cochran Firm, D.C. is currently accepting claims from Alere INRatio and INRatio2 users who suffered serious bleeding injuries after relying on the medical device’s erroneous PT/INR readings. Please contact us at 202-682-5800, or 24/7 at 1-800-THE-FIRM (843-3476), or fill out a contact form to receive a prompt, free, and confidential case review. Strict time limits apply to filing a claim, so please contact us at your earliest convenience.